A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01692132|
Recruitment Status : Withdrawn (The company decided to cancel this study in conformity with PH FDA Circular 2013-004)
First Posted : September 25, 2012
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment|
|Chronic Constipation||Drug: Prucalopride|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||December 2014|
Prucalopride 2 mg tablet/day orally for 12 weeks. For elderly patients (>65 years old), patients with renal impairment not requiring dialysis or patients with severe hepatic impairment, 1mg prucalopride once daily should be given.
- The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions [ Time Frame: 12 weeks ]
- The percentage of patients having at least 3 spontaneous complete bowel movements (SCBM) in a week after treatment with prucalopride [ Time Frame: 12 weeks ]SCBM is defined as a sense of complete evacuation of bowel without straining.
- The change from baseline in the Patient Assessment of Constipation Symptoms (PAC-SYM) score after treatment with prucalopride [ Time Frame: Baseline, 12 weeks ]The PAC-SYM questionnaire is a 12-item survey that measures constipation symptoms and associated severity across three domains: stool symptoms, rectal symptoms, and abdominal symptoms. Symptom items are rated on a 5-point Likert severity scale. Item values are scored from 0 to 4, with 0 indicating absence of symptom, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe indicating the worst severity of that symptom.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692132
|Makati City, Philippines|
|Marikina City, Philippines|
|Quezon City, Philippines|
|San Juan, Philippines|
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|